|
FORMAT
BOOKS
PACKAGES
EDITION
PUBLISHER
CONTENT TYPE
Act
Admin Code
Announcements
Bill
Book
CADD File
CAN
CEU
Charter
Checklist
City Code
Code
Commentary
Comprehensive Plan
Conference Paper
County Code
Course
DHS Documents
Document
Errata
Executive Regulation
Federal Guideline
Firm Content
Guideline
Handbook
Interpretation
Journal
Land Use and Development
Law
Legislative Rule
Local Amendment
Local Code
Local Document
Local Regulation
Local Standards
Manual
Model Code
Model Standard
Notice
Ordinance
Other
Paperback
PASS
Periodicals
PIN
Plan
Policy
Product
Program
Provisions
Requirements
Revisions
Rules & Regulations
Standards
State Amendment
State Code
State Manual
State Plan
State Standards
Statute
Study Guide
Supplement
Technical Bulletin
All
|
Description of ASTM-F3169 2016ASTM F3169-16Active Standard: Standard Test Method for Leak Detection in Blister Packaging by Vacuum Deflection Method by Laser MeasurementASTM F3169Scope 1.1 Test Packages—This test method can be applied to non-porous blister packs sealed with flexible films such as those used in pharmaceutical packaging. Such blister packs typically consist of thermoformed polymer or cold formed aluminum trays that contain a number of individual blister pockets into which tablets or capsules are placed. The trays are then sealed with a polymer, paper-backed or foil-based flexible laminate lidding material. 1.2 Leaks Detected—This test method detects leaks in blister packs by measuring the deflection of the blister pack surface in response to an applied vacuum. This deflection of the blister pack surface results from the difference in pressure between the gas inside the blister pack and the applied vacuum. Air loss from within a blister pocket as a result of a leak will alter this pressure differential causing a measureable variation in blister pocket deflection. This test method requires that the blister packs are held in appropriate tooling inside a suitable test chamber. 1.3 Test Results—Test results are reported qualitatively (pass/fail). Appropriate acceptance criteria for deflection, height, and collapse values are established by comparing non-leaking packs with those containing defects of a known size. Suitably sized defects in the laminate, tray material, and seal can be detected using this test method. The sensitivity of this test method depends upon a range of factors including blister pocket headspace, blister pocket size, lidding material type, lidding material thickness, lidding material tension, printing, surface texture, test conditions, and the values selected for the pass/fail acceptance criteria. The ability of the test to detect 15 µm, 50 µm, and catastrophic sized holes in four blister pack designs was demonstrated in a study. 1.4 The values stated in SI units are to be regarded as standard and no other units of measurement are included in this test method. 1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. Keywords blister packing; flexible packaging; leak testing; package integrity; pass/fail criteria; pharmaceutical packaging; vacuum leak test; ICS Code ICS Number Code 55.040 (Packaging materials and accessories) DOI: 10.1520/F3169-16 This book also exists in the following packages...Subscription InformationMADCAD.com ASTM Standards subscriptions are annual and access is unlimited concurrency based (number of people that can access the subscription at any given time) from single office location. For pricing on multiple office location ASTM Standards Subscriptions, please contact us at info@madcad.com or +1 800.798.9296.
Some features of MADCAD.com ASTM Standards Subscriptions are: - Immediate Access: As soon as the transaction is completed, your ASTM Standards Subscription will be ready for access.
For any further information on MADCAD.com ASTM Standards Subscriptions, please contact us at info@madcad.com or +1 800.798.9296.
About ASTMASTM International, formerly known as the American Society for Testing and Materials (ASTM), is a globally recognized leader in the development and delivery of international voluntary consensus standards. Today, some 12,000 ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence. ASTM’s leadership in international standards development is driven by the contributions of its members: more than 30,000 of the world’s top technical experts and business professionals representing 150 countries. Working in an open and transparent process and using ASTM’s advanced electronic infrastructure, ASTM members deliver the test methods, specifications, guides, and practices that support industries and governments worldwide. |
GROUPS
|
|
MADCAD.com
by Compu-tecture, Inc.
|
Contact Us
3000 Connecticut Ave, NW
Suite 200
Washington, DC 20008
+1 800.798.9296
+1 202.265.1940
|
|
Partnerships
|